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I don’t understand why this has to go through a clinical trial. He said that it must be used by a doctor. I guess because only they know how to use electronics. Then 10 minutes later he said that he taught someone to use it in one day. Maybe I misunderstood. It just doesn’t look that complicated.

What is even crazier is that if they put this on the market and didn't say it had any health benefits, then it could go through a different process which would take no time at all.
But then doctors wouldn't be able to prescribe it, and healthcare wouldn't pay for it.
For example, look at all the TMS devices on the market, surely they are far more dangerous. They get around it by not advertising any medical benefits.

I wanted them to go this route first, to get the devices to anyone who wanted to try it with no guarantees. Then go down the medical cert route secondary.

Unfortunately thats not seen as a good idea by some others, I suspect others who are worrying about any financial implications and not the fact that people with injuries want something now.

What is even crazier is that if they put this on the market and didn't say it had any health benefits, then it could go through a different process which would take no time at all.
But then doctors wouldn't be able to prescribe it, and healthcare wouldn't pay for it.
For example, look at all the TMS devices on the market, surely they are far more dangerous. They get around it by not advertising any medical benefits.

I wanted them to go this route first, to get the devices to anyone who wanted to try it with no guarantees. Then go down the medical cert route secondary.

Unfortunately thats not seen as a good idea by some others, I suspect others who are worrying about any financial implications and not the fact that people with injuries want something now.

Exactly! Is it required by law or by wording. There is a difference! CBD oil and supplements get around this every day just by wording. At the end of the day it’s about insurance. They will pay more and that has everything to do with it. An yes I understand the health issue with it but jeez it’s a glorified tens unit. It can’t do but so much damage.

Exactly! Is it required by law or by wording. There is a difference! CBD oil and supplements get around this every day just by wording. At the end of the day it’s about insurance. They will pay more and that has everything to do with it. An yes I understand the health issue with it but jeez it’s a glorified tens unit. It can’t do but so much damage.

No, it is much more than a glorified TENS unit.

It provides much more powerful stimulation that goes much deeper in to the body than a TENS unit, and has more potential to permanently damage the skin of someone with an SCI. The full potential of its effects on neural circuits are also still not yet understood.

It provides much more powerful stimulation that goes much deeper in to the body than a TENS unit, and has more potential to permanently damage the skin of someone with an SCI. The full potential of its effects on neural circuits are also still not yet understood.

Thats true, but its much less than implantable devices that people have been using for pain management for years.
So in terms of safety this type of technology has already been through a load of testing.
The difference is that it wasn't for SCI, so it can't be marketed as such.

It provides much more powerful stimulation that goes much deeper in to the body than a TENS unit, and has more potential to permanently damage the skin of someone with an SCI. The full potential of its effects on neural circuits are also still not yet understood.

Not sure where you got this information. The innovation isn't massive power but multiple frequencies and tailored waveforms and the FDA process is simpler because they're testing under the FES umbrella.

What is even crazier is that if they put this on the market and didn't say it had any health benefits, then it could go through a different process which would take no time at all.
But then doctors wouldn't be able to prescribe it, and healthcare wouldn't pay for it.
For example, look at all the TMS devices on the market, surely they are far more dangerous. They get around it by not advertising any medical benefits.

I wanted them to go this route first, to get the devices to anyone who wanted to try it with no guarantees. Then go down the medical cert route secondary.

Unfortunately thats not seen as a good idea by some others, I suspect others who are worrying about any financial implications and not the fact that people with injuries want something now.

This is a common misconception. You can't just ignore regulatory requirements by making no claims about health benefits. It's more complicated than that. That would be like saying you could sell guns to people while ignoring the regulatory requirements, simply by putting a sticker on it that says, "This is definitely NOT a gun."

The companies that do sell medical devices without following regulatory requirements are breaking the law. However, like any law enforcement agency, the FDA has a limited amount of resources, so it has to put its efforts towards ensuring that the biggest risks are covered. TENS devices are very low risk devices. FES bikes are a little riskier. Implanted stimulators are extremely risky. Transcutaneous spinal cord stimulators fall somewhere between TENS units and implanted stimulators, in terms of risk. The problem is, no one can say definitively yet where on that spectrum they're located. Therefore, clinical trials are being conducted to answer that question and to determine whether the risks outweigh the benefits.

Doctors generally don't make money off prescriptions (anti-kickback laws), and healthcare hardly pays for anything these days. It's much more a safety and efficacy issue than a financial one.

Co-founder & CTO of MYOLYN - FES Technology for People with Paralysis - Empowering People to Move

Not sure where you got this information. The innovation isn't massive power but multiple frequencies and tailored waveforms and the FDA process is simpler because they're testing under the FES umbrella.

Tommy's probably referring to some of the transcutaneous designs that pass current all the way through the torso. These do require more power than your standard off-the-shelf stimulator has.

Co-founder & CTO of MYOLYN - FES Technology for People with Paralysis - Empowering People to Move